Research and Development

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Trump’s FDA: Is the US regulator being steered by the President?

September 9, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump, US, drug safety, pharma

FDA activity has fallen under Donald Trump, with the number of warning letters issued by the regulator dropping by a …
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4.5-year data confirms long-term efficacy of Novartis’ Aimovig in episodic migraine

September 9, 2019 Research and Development, Sales and Marketing Aimovig, Novartis, migraine, pharma

Novartis has lifted the curtain on interim data from the 4.5-year mark of a five-year open-label treatment period (OLTP) investigating …
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Top Ten most popular articles on Pharmafile.com this week

September 6, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, Mylan, brexit

It’s Friday, meaning the weekend is within reach and it’s time for a rundown of the most popular articles on …
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Boehringer and Lupin team up to battle KRAS-driven cancers in $700m+ deal

September 5, 2019 Research and Development, Sales and Marketing Boehringer Ingelheim, Cancer, KRAS, Lupin, collaboration, pharma

Boehringer Ingelheim is set to join forces with Lupin after the pair sealed a partnership agreement to develop, license, and …
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BMS’ Opdivo falls short at Phase 3 in glioblastoma multiforme

September 5, 2019 Research and Development BMS, glioblastoma multiforme, opdivo, pharma

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy Opdivo (nivolumab) fell short of its primary Phase 3 endpoint in the …
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Cancer drugs have surged since the 80s to account for 1 in 4 FDA approvals, report reveals

September 5, 2019 Research and Development, Sales and Marketing Cancer, FDA, US, pharma

The number of cancer drug approvals in the US has surged over the last decade to account for over one …
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Key legal considerations in accelerating pharma using artificial intelligence

September 4, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AI, artificial intelligence, pharma

Charlotte Walker-Osborn, Partner and International Technology Sector Head and Nabil Asaad, Senior Associate, Intellectual Property Law Group – both from …
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FREE WEBINAR: Leveraging technology for optimal engagement

September 4, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Pharmafocus, Webinar, Within3, pharma

Join Pharmafocus and Within3 for a special webinar event on Thursday, 19 September, for a session exploring the changing trends …
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Keytruda scores EU approval in combination with Inlyta for first-line advanced renal cell carcinoma

September 4, 2019 Research and Development, Sales and Marketing EU, Europe, MSD, keytruda, pharma, renal cell carcinoma

The European Commission has awarded yet another authorisation in the region to MSD’s Keytruda, this time in combination with the …
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Ardelyx’s tenapanor combo meets all key goals at Phase 3 in hyperphosphatemia patients on dialysis

September 4, 2019 Research and Development Ardelyx, pharma, tenapanor

Ardelyx has revealed that its small molecule, non-binder, phosphate absorption inhibitor tenapanor met all primary and key secondary endpoints at …

NICE recommends Novartis’ gene therapy Luxturna for inherited retinal dystrophy

September 4, 2019 Research and Development, Sales and Marketing Luxturna, NHS, NICE, UK, gene therapy, pharma

NICE has chosen to recommend the use of Novartis’ one-time gene therapy Luxturna (voretigene neparvovec) for use on the NHS …
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AZ’s Tagrisso secures China approval in first-line advanced lung cancer

September 4, 2019 Research and Development, Sales and Marketing AstraZeneca, China, Tagrisso, lung cancer, pharma

AstraZeneca’s Tagrisso (osimertinib) has secured approval in China from the country’s National Medical Products Administration (NMPA) in the first-line treatment …
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NICE issues new quality standard for cerebal palsy treatment

September 3, 2019 Manufacturing and Production, Research and Development

NICE has moved to publish a draft quality standard on the treatment of cerebral palsy (CP) in adults, it has …
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Novartis’ ofatumumab outclasses Sanofi’s Aubagio at Phase 3 in relapsing multiple sclerosis

September 3, 2019 Manufacturing and Production, Research and Development Arzerra, Genmab, Novartis, multiple sclerosis, pharma

New data from two Phase 3 studies have indicated that Novartis’ ofatumumab outperformed Sanofi Genzyme’s Aubagio (teriflunomide) in the treatment …
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AstraZeneca shows off Farxiga heart failure efficacy at ESC 2019

September 3, 2019 Manufacturing and Production, Research and Development

AstraZeneca has revealed new Phase 3 data illustrating that Farxiga (dapagliflozin), in combination with standard of care, met its primary …
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